SPECULUM

FIELD OF THE INVENTION

The invention relates to a speculum for allowing a user to inspect a body cavity, to a kit comprising said speculum and to a method of obtaining a cell sample from a body cavity comprising said speculum.

BACKGROUND OF THE INVENTION

A speculum is a medical tool well known in the art that is used by health practitioners for inspecting a variety of body cavities. Generally, the device contains adjustable blades that move from a first position, where the blades lie adjacent to one another in a closed formation, to a second position, where the blades are moved apart from one another into an open formation. Once the blades are moved apart, an inspection channel forms which allows the inside of the body cavity to be seen.

A speculum is commonly used to perform a cervical smear test on a female patient by using the speculum to open the vagina to gain access to the cervix and collect a sample of cells. The collected cells are then 'smeared' onto a slide or suspended in a vial of fluid and sent to the appropriate testing facility. A cervical smear test is used in the diagnosis of cervical cancer, one of the most common types of cancer in women.

It is recommended that women have a cervical smear test once every three years. However, the uptake by women is lower than desirable and many put off taking the test making the interval between taking tests longer than recommended. Many factors are involved in not taking the test, such as the stress of having such a test and women being too busy to arrange and attend an appointment. Delays can also occur if a collected sample is thought to be inadequate for testing, such as the presence of blood or an insufficient number of cells, resulting in a second smear test needing to be performed.

Currently, speculums are used by health practitioners to view body cavities of their patients. Health practitioners usually have to use a light source located behind them which can be positioned so as to illuminate the body cavity. This can often be awkward if the cavity needs to be inspected closer or a sample needs to be collected because movement of the health practitioner can obscure the light and cast a shadow on the inspected cavity.

WO2006/136844 discloses a speculum with an attached mirror for use in performing cervical smear tests. A single light source is incorporated into the cell collecting brush to act as a light guide.

An object of the invention is to provide an improved speculum to enhance the cell sampling procedure.

SUMMARY OF THE INVENTION

According to a first aspect of the invention there is provided a speculum for allowing a user to inspect a body cavity which comprises more than one light source characterised in that each of said light sources emits a light beam which is angled towards a position of interest within the inspected body cavity.

According to a second aspect of the invention there is provided a speculum for allowing a user to inspect a body cavity which comprises at least one light source configured to illuminate at least a portion of said body cavity.

According to a further aspect of the invention there is provided a kit comprising a speculum as defined herein and a cell sample collector.

According to a further aspect of the invention there is provided a method of obtaining a cell sample from a body cavity which comprises:

a) insertion of a speculum as defined herein into the body cavity;

b) opening of the speculum to form an inspection channel that extends through the body cavity;

c) activation of the light source;

d) visualisation of the body cavity; and

e) collection of a cell sample using a cell sample collector as defined herein. According to a further aspect of the invention there is provided a method of a user obtaining a cell sample from their own body cavity which comprises:

a) insertion of a speculum as defined herein into their body cavity; b) opening of the speculum to form an inspection channel that extends through the body cavity;

c) activation of the light source;

d) visualisation of the body cavity by adjusting a mirror or camera; and

e) collection of the cell sample using a cell sample collector as defined herein.

According to a further aspect of the invention there is provided a speculum for allowing a user to inspect a body cavity which comprises a mirror and at least one light source configured to illuminate at least a portion of said body cavity wherein said light source is incorporated within said mirror.

According to a further aspect of the invention there is provided a mirror for inspecting a body cavity comprising more than one light source incorporated therein, wherein each of said light sources is configured to emit a light beam which is angled towards a position of interest within the inspected body cavity.

BRIEF DESCRIPTION OF THE FIGURES

Figures 1 & 2 : Perspective views of an embodiment of the speculum of the present invention. Both views show the device with blades in an open formation.

Figure 3 : Exploded view of a mirror with an incorporated light source, to be attached to a speculum as described herein.

Figure 4: Side view of an embodiment of the speculum of the present invention. The Figure depicts a configuration of the light sources described herein, so that the light emitted diverges to create a vertically elongated area of intense light within a body cavity, such as the vagina. Figure 5 : Plan view of an embodiment of the speculum of the present invention. The Figure depicts a configuration of the light sources described herein, so that the light emitted converges within a body cavity, such as the vagina.

DETAILED DESCRIPTION OF THE INVENTION

According to a first aspect of the invention there is provided a speculum for allowing a user to inspect a body cavity which comprises more than one light source characterised in that each of said light sources emits a light beam which is angled towards a position of interest within the inspected body cavity.

With the light located on the speculum, the user has the benefit of being able to clearly and easily visualize the inspected body cavity. Previous devices require a light located behind the user or on a collecting brush held separately by the user, often making the process of inspecting the body cavity awkward.

References herein to "speculum" refer to a device used as a medical tool to inspect body cavities and is well known in the art. Speculums may have adjustable blades that can be moved from a first, closed position to a second, open position allowing the formation of an inspection channel which allows the user to obtain a direct visual of the inside of a body cavity. Such references include speculum devices with two blades ("bivalve speculums"), four blades and multiple blades. The blades can be shaped in such a way so as to provide the most comfortable fit for insertion into a body cavity.

Speculums can be constructed from a variety of materials, such as hard, rigid plastics suitable for medical use. Such plastics include acrylonitrile butadiene styrene (ABS), styrene, polycarbonate, polypropylene, polyvinyl chloride (PVC), acrylic or ABS-polycarbonate mixes. Speculums can also be constructed from metal, such as stainless steel. In one embodiment, the internal surfaces of the speculum are white and/or have a polished surface finish. This embodiment provides the advantage of minimizing light loss and reflects the maximum amount of light into the body cavity. Speculums may have various mechanisms that allow the opening of the blades, such as involving a ring having a cam surface that is movable along a path that lies around or outside the opening. The blades may then be locked into an open position through use of a locking mechanism, such as a screw thread, or without the use of a locking mechanism, such as friction of an outer ring against an inner ring with a series of outwardly projecting protrusions along a cam surface.

In speculums involving an inner ring within an outer ring, there may be a series of protrusions around the circumference of the inner ring which are angled so that there is a degree of friction between the inner ring and the outer ring. In one embodiment, the friction created by the inner ring protrusions against the outer ring may be such that it prevents the blades from closing against the natural closing effect of the body cavity, but can be easily overcome by the user applying manual force on the ring handles when they wish to close the speculum blades. This arrangement has the advantage that it creates a degree of friction which maintains the blades in the open position without the need for a locking mechanism.

In one embodiment, the protrusions on the inner ring can be positioned at various intervals so that the blades can be held open at a range of angles. This allows the user to choose the best angle to open the blades for maximizing the visibility of the inside of the body cavity.

The speculum body can include a grip to assist in insertion of the device into a body cavity and help with its correct placement.

In speculums involving a ring with a cam surface, the ring may include at least one handle extending away from the opening in the speculum body, enabling the user to rotate the ring. The design of the handle on the ring could be such that it is suitable for right and left handed users. The handle can be arranged so that it does not obstruct the visual pathway through the inspection channel, such as by locating the handle outside the opening in the speculum body and positioning the handle so that it points away from the centre of the ring. In one embodiment, the speculum may have two handles located opposite each other and so that they extend away from the centre of the ring. It will be appreciated that the light sources may be configured directly to angle the beam of light towards the position of interest within the inspected body cavity. Thus, in one embodiment, the light sources are angled towards a position of interest within the inspected body cavity. Such an arrangement may typically comprise the use of two or more light sources (such as LEDs) the legs of which are bent or angled so that the LEDs point in a direction such that their light beams converge at the position of interest (i.e. the probable location of the cervix where the body cavity is the vagina). The direction of the LEDs may be accurately maintained by virtue of the presence of a moulded plastic component which has a tubular channel for each LED and which points in the correct direction.

Alternatively, the light sources may be in a fixed parallel position relative to each other and the light beams emitted may be angled by the presence of additional component, such as a lens, light guide or equivalent component. Thus, in an alternative embodiment, the speculum additionally comprises a lens or equivalent component configured to angle the light beam emitted from each light source towards a position of interest within the inspected body cavity. Such an arrangement may typically comprise the use of two or more light sources (such as LEDs) which have a moulded plastic lens component lying in front of the LEDs to retract or focus the light beams to converge at the position of interest (i.e. the probable location of the cervix where the body cavity is the vagina).

References herein to "body cavity" refer to a space inside a patient, such as a human or animal. Examples of body cavities include vaginal, rectal, nasal, aural and oral cavities. In one embodiment the body cavity is the vagina to allow inspection of the cervix.

References herein to "light source" refer to objects with the ability to emit light, such as filament light bulbs, light-emitting diodes (LEDs), incandescent lamps, halogen lamps, fluorescent lamps, high-intensity discharge lamps, lasers and torches. In a further embodiment, the speculum comprises two light sources configured to illuminate at least a portion of said body cavity. In one embodiment, the light sources are selected to have the narrowest possible beam. This embodiment provides the advantage of being able to lose the minimum amount of light as the light travels through the speculum to the internal surface of the body cavity.

In a further embodiment the light sources are configured to emit light which converges at a position of interest within said body cavity.

This embodiment provides an arrangement wherein the light sources are angled so that their beams of light converge at a position of interest within the body cavity. It will be appreciated that the area or point at which the light beams converge will generally be the position within the cavity in which a cell sample is required to be collected.

In one example the speculum may be used to inspect a body cavity such as the vagina and the light sources emit light that converges within the vagina at the probable position of the cervix, as shown in Figure 5. This embodiment provides the substantial advantage of making it easier for the user to see and acts as a useful guide to the location of the cervix.

In an alternative embodiment, the light sources are configured to emit light which diverges within said body cavity. In one embodiment the light sources are angled so that their beams of light diverge at the probable location of the cervix, with one above the other, as shown in Figure 4. This has the advantage of creating a vertically elongated area of intense light which is most likely to capture the location of the cervix and help identify it.

The light sources are designed to achieve the maximum light intensity at the probable location of the cervix. This increases the probability of a user being able to guide a cell sampling device to the correct position and collect a suitable cervical cell sample.

References herein to a "position of interest" refer to particular locations within the body cavity that a user wishes to inspect. It will be appreciated that the position of interest will generally be the area or point within the cavity in which a cell sample is required to be collected. For example, the speculum may be used to inspect a body cavity such as the vagina where the position of interest is the cervix.

It will be appreciated that the first aspect of the invention relates to an arrangement wherein the light sources are configured to be angled so that their light beams either converge or diverge. In one embodiment the light sources are angled so that their beams of light converge at the position of interest, such as at the probable location of the cervix, as shown in Figure 5. Converging light beams can act as useful guides to pinpoint areas within the body cavity, thus helping the user to identify the position of interest.

In an alternative embodiment, the light sources are configured to emit light which diverges at the position of interest. Diverging light beams can create a greater area of intense light, thus maximizing the likelihood of the user being able to locate the position of interest. For example, the light sources may be angled so that their beams of light diverge at the probable location of the cervix, with one above the other, as shown in Figure 4. This has the advantage of creating an elongated area of intense light which is most likely to capture the location of the cervix and help identify it.

According to a second aspect of the invention there is provided a speculum for allowing a user to inspect a body cavity which comprises at least one light source configured to illuminate at least a portion of said body cavity.

In one embodiment of the second aspect of the invention, the speculum comprises more than one light source configured to illuminate at least a portion of said body cavity. This embodiment provides the advantage of greater illumination within the body cavity.

In one embodiment of the second aspect of the invention, the speculum comprises more than one light source wherein each of said light sources are configured to be angled relative to each other. In one embodiment, the speculum additionally comprises a mirror. This embodiment provides the advantage of allowing the user to view their own body cavity to ensure correct placement of the device and sampling of the cells.

References herein to "mirror" include surfaces that are configured to reflect radiation passing along the body cavity. Mirrors may be planar or curved, concave or convex and formed out of any reflective material.

In one embodiment, the light source is incorporated within said mirror. This embodiment provides the advantage of ensuring that the beam of light follows the direction of the mirror such that the area the user is viewing is simultaneously illuminated.

For example, in one arrangement the mirror may comprise a casing which allows for the attachment of a light source thereby illuminating the area which the mirror is reflecting. In an alternative embodiment, the mirror comprises the light source incorporated within or behind the surface of the mirror. This embodiment provides the advantage of allowing the device to be easily cleaned or sterilized after use rather than one where the light source is separately connected to the speculum or collecting brush.

According to a further aspect of the invention there is provided a speculum for allowing a user to inspect a body cavity which comprises a mirror and at least one light source configured to illuminate at least a portion of said body cavity wherein said light source is incorporated within said mirror.

According to a further aspect of the invention there is provided a mirror for inspecting a body cavity comprising more than one light source incorporated therein, wherein each of said light sources is configured to emit a light beam which is angled towards a position of interest within the inspected body cavity.

It will be appreciated that the embodiment above relates to an arrangement wherein the light sources are configured to be angled so that their light beams either converge or diverge in accordance with the embodiments herein described. In a further embodiment, the light source comprises an LED.

References herein to "LED" or "light-emitting diode" refer to a semiconductor diode that has the ability to emit light when a current flows through it. These include semiconductor LEDs, organic LEDs and polymer LEDs. LEDs have the advantage of being small, with a relatively long lifetime and are relatively durable.

In one embodiment the mirror may be moveable. References herein to "moveable" refer to something that is capable of being moved. Such references include similar terms such as "adjustable", "portable" or "flexible". The invention may be used by a person wishing to inspect their own body cavity therefore it is advantageous for the mirror to be adapted to move so that it can be positioned as required. In one embodiment the mirror may include a handle designed to help the user adjust the mirror into the correct position.

In a further embodiment the mirror may be detachable. The invention may be used by health practitioners therefore this embodiment is advantageous by allowing the user to remove the mirror from the device so that it does not obstruct the view of the body cavity.

The speculum may have a pair of opposed arms for holding the detachable mirror. The mirror can be a variety of shapes, such as a round, circular shape. In one embodiment the backing to the mirror may be dome-shaped as this helps the user to move and position the mirror as required. In some embodiments the mirror may have a groove which helps to steady the rod of the cell sample collector and can act as a guide for positioning the cell sample collector. The mirror arms can be of various lengths, such as in one embodiment approximately 5-lOcm long, or in a further embodiment 7-9cm long.

In one embodiment the speculum additionally comprises a battery unit.

References herein to "battery unit" refer to a power source that would, in one example, be used to power the light source. In one embodiment, the battery unit comprises a battery used to power an LED. In a further embodiment, the mirror casing comprises a removable tab which acts as an isolator for the battery in order to extend the shelf-life of the speculum .

In another embodiment the speculum comprises a camera capable of recording an image along the inspected body cavity. This embodiment has the advantage of allowing the user to view their body cavity but also to download images which may be sent with the cell sample to allow an expert to verify that the sample has been accurately obtained.

In one embodiment the speculum additionally comprises a cell sample collector.

For example, a cell sample collector may comprise a rod with a cell sample collecting head. The rod may also comprise a handle on the opposite end to the cell sample collecting head. The cell sample collector may be used to collect cells from the inside of the body cavity for subsequent testing.

In a further embodiment the cell sample collector comprises a brush.

References herein to "brush" refer to a tool with bristles set into a base. In one embodiment the brush is of a standard type used for taking cell samples, such as cervical smears for cervical smear testing. The brush may include a connector for push-fitting the brush onto the rod of the cell sample collector.

In one embodiment, a cell sample is taken from the cervix by maintaining pressure from the brush against the cervix at the required level which causes the brush bristles to flex and then revolving the brush to collect the cells.

In a further embodiment the speculum additionally comprises a cervical cell sample collector.

In one embodiment, the cervical cell sample collector may include a pressure sensor so that when the brush is applied against the cervix with the required pressure a visual or audible alert could be given to indicate the correct pressure has been applied. This helps to increase the likelihood of obtaining a good sample. In one embodiment a pressure-sensitive switch can be provided in a switch casing to be located within the handle of the cell sample collector rod. Therefore, a force tending to push the rod further into the handle will put pressure on the switch until it exceeds a threshold value causing the switch to be affected and a visual or audible signal to be given out.

In one embodiment the blades of the speculum can act to protect the cervical cell sample collector during insertion or removal from the vagina.

Optionally, one of the blades may comprise a holder, for example a snap fit mechanism, on its inner surface that may be used to hold the cell sample collector. The cell sample collector can thereby be preloaded into the speculum before insertion so as to simplify the procedure and reduce the risk of contamination of the collector and sample. In this embodiment there is enough space within the cavity of the blades and between the cell sample collector holder and the end of the blades to accommodate a brush head of the sample collector.

In an alternative embodiment, optionally one of the blades may comprise a support, for example a U-shaped support, on its inner surface that can act as a support and/or fulcrum for the rod of the cell sample collector. This embodiment enables the user to have a greater control over the rod of the cell sample collector as the brush head is positioned within the body cavity.

According to a further aspect of the invention there is provided a kit comprising a speculum as defined herein and a cell sample collector. In one embodiment, the cell sample collector is provided in a sterile, protective packaging.

The kit could also contain instructions for use, such as in the form of a leaflet or compact disc, or a DVD, so as to increase the likelihood accurate samples are taken. In a further embodiment the kit could contain a lubricating agent.

In one embodiment the kit may additionally comprise at least one vial containing alcohol (such as ethanol and/or methanol) to preserve the sample. This helps protect the sample from the time it takes to collect the sample until it is received at the appropriate testing facility.

In one embodiment the vial is cylindrical and has a diameter greater than the width of the brush. In a further embodiment the vial comprises a pair of opposed internal ridges. The ridges may suitably be located part way down the vial wall or on the inside of the vial lid, so that they are spaced apart by less than the width of the brush . This embodiment allows for the brush to be inserted into the vial or lid parallel to the ridges, before twisting the brush through an angle, such as 90°, so that the brush is caught under the ridges and the rod can be pulled apart from the brush head. This embodiment also enables the brush head to be collected inside the vial without the need to detach the brush head by hand and avoids any risk of contamination.

The alcohol solution provided in the vial to preserve the cell sample can be any type of alcohol solution suitable for preservation, such as 95% ethanol.

In another embodiment, a microscope slide can be used to collect the cell sample from the brush head, rather than collection of the brush head occurring in a vial or any other type of sample carrier.

The kit components of the speculum and cell sample collector could be intended for single use only. Alternatively, the rod and speculum could be boiled to sterilize them after each use and kits containing replacement parts, such as the cell sample collector brush head and vial with preservative solution, could be sold separately.

According to a further aspect of the invention there is provided a method of obtaining a cell sample from a body cavity which comprises:

a) insertion of a speculum as defined herein into the body cavity;

b) opening of the speculum to form an inspection channel that extends through the body cavity;

c) activation of the light source;

d) visualisation of the body cavity; and e) collection of a cell sample using a cell sample collector as defined herein.

According to a further aspect of the invention there is provided a method of a user obtaining a cell sample from their own body cavity which comprises:

a) insertion of a speculum as defined herein into their body cavity; b) opening of the speculum to form an inspection channel that extends through the body cavity;

c) activation of the light source;

d) visualisation of the body cavity by adjusting a mirror or camera; and

e) collection of the cell sample using a cell sample collector as defined herein.

It will be appreciated that step (c) in the methods of the above mentioned aspects of the invention may be conducted at any time prior to visualisation step (d). For example, the light source may be activated prior to step (a) or prior to step (b).

The sampling methods of the invention enable a person to use the speculum on themselves, without the need for external help. One embodiment of this method would be to allow a user to obtain a cervical sample herself, without the need for a health practitioner. The method can be performed in the comfort and privacy of her own home and at a time of her own choosing, without the need to arrange an appointment and visit a doctor's surgery. These advantages make it more likely women will take a smear test at the recommended time, thereby increasing the number of women diagnosed with cervical cancer early enough for treatment to be successful.

The invention will now be described, by way of example only, with reference to the accompanying Figures.

Referring first to Figures 1 and 2, a speculum shown generally as 100, typically comprises two blades 1,2 where one blade 1 is pivotally connected to the speculum body 200 while the other 2 is integral with the device body 200. The first blade 1 is pivotally connected to the speculum body 200 by a pair of hinge pins 5 that engage in corresponding hinge pin sockets 6.

The blades 1,2 are shaped so that the inside surface is generally concave and defines an internal space 10, while the outer surface is convex. The blades 1,2 taper towards the proximal, insertion ends of the blade 15 resulting in the blades 1,2 forming an overall conical shape.

The mechanism controlling the opening and closing of the blades 1,2 involves an inner ring 25 that fits within an outer annulus 30. The outer surface of the inner ring 25 has a groove that engages with a series of projections from the inside surface of the outer annulus 30. This allows the inner ring 25 to turn within the outer annulus 30. The groove of the inner ring 25 only extends part way around the inner ring 25 thereby limiting the angle through which the inner ring 25 may be turned. This restriction means the inner ring 25 can only be turned 90° within the outer ring 30.

The inner ring 25 comprises two handles 35,36 located opposite each other and extending away from the centre of the ring. The handles 35,36 are used to rotate the inner ring 25 within the outer annulus 30.

The inside surface of the inner ring 25 has a cam surface. One end of the first blade 1, which is pivotally connected to the speculum body 200, extends backwards so that it lies within the inner ring 25 and engages with its inner surface. When the blades 1,2 are in the closed formation (not shown) the cam does not engage with the end of the blade 1; however, when the inner ring 25 is rotated, the cam surface engages with the end of the blade 1, causing it to pivot about the hinge pins 5 and separate the blades into the open formation (shown in Figures 1 and 2). Rotating the inner ring 25 in the opposite direction disengages the blade 1 from the cam surface and causes the pivoted blade 1 to move back towards the fixed blade 2, into the closed formation. The

arrangement is such that by turning the inner ring 25 through 90° the speculum can be fully opened. The cam surface of the inner ring 25, has a series of protrusions which are angled so that there is a degree of friction between the inner ring 25 and the outer ring 30. This friction retains the pivoted blade 1 in the open position without the need for a locking mechanism. The friction can be overcome by the user applying manual force to the inner ring 25 and rotating it so that the blades 1,2 become closed.

The protrusions on the inner ring 25 are positioned at various intervals so that the blades 1,2 can be held open at a range of angles likely to provide a suitable aperture in order to view the cervix.

Towards the distal, viewing end of the speculum 20 shown, there is a pair of opposed arms 45,46 that hold a detachable mirror 50. The mirror 50 is generally round and held within a casing 55 that is dome-shaped for ease of handling and so that the mirror can be adjusted into the correct position by the user.

Optionally, at the base of the mirror 50 there is a groove which can be used when positioning the cell sample collector.

The casing 55 comprises a removable tab 65 which acts as an isolator for the battery. The tab 65 is removed by the user prior to first use of the device in order to be able to activate the light source. The casing 55 additionally comprises a switch 70 to activate the light source which is concealed behind the surface of the mirror 50.

Figure 3 shows the various components of the mirror 50, held at the distal, viewing end of the speculum 20, in an exploded view. The casing 55

accommodates a switch 70 which is connected to a battery unit (not shown) used to power two LEDs 75,76 held within the mirror casing 55. The LEDs 75,76 are positioned at precise angles by a housing 80, so that the light beams 250,260 converge or diverge. The LEDs 75,76 are contained within the casing 55 behind the mirror 50.

Figure 4 shows the divergence of the LED light beams 250,260 in a side view of the speculum 100. The open blades 1,2 of the speculum 100 create an aperture at their tip 15 which is higher than it is wide. Therefore, the LEDs 75,76 are angled slightly so that their light beams 250, 260 arrive at the probable location of the cervix 300 with one above the other, creating a vertically elongated area of intense light. The mirror 50 can be angled so that the viewer 210 can see a reflection 220 of the internal surface of the body cavity.

Figure 5 shows the convergence of the LED light beams 250,260 in a plan view of the speculum 100. The LEDs 75,76 are angled in plan so that their beams intersect 270 at a position which corresponds to the probable location of the cervix 300 and on the centerline of the speculum 280.

In use, the speculum 100 may be used to collect a cell sample from a woman's cervix 300. The cell sample collector is assembled by push-fitting the brush head onto the end of the rod via the connector. The sterile cover is removed from the brush head at this stage.

The proximal, insertion end of the speculum 15 is inserted into the vagina and the blades 1,2 are opened by rotating the handles 35,36 in an anti-clockwise direction from the practitioner's perspective or clockwise direction from the user's perspective. The LEDs 75,76 are then activated by clicking the switch 70 so that the body cavity is illuminated. The LEDs 75,76 are configured to emit light 250,260 which either converges at an area or point which illuminates the cervix 300 (Figure 5) or diverges to create an elongated area of light within the cavity (Figure 4).

In both arrangements, the mirror 50 is positioned so that the user can see the cervix 300 illuminated by the converging or diverging LED light beams 250,260. Once the cervix 300 has been located, the cell sample collector can be inserted between the open blades 1,2 and into the cavity. Using the converging or diverging light beams 250,260 as a guide, the user can then direct the tip of the brush to the centre of the cervix 300.

Optionally, the jaws of the speculum may contain a clip holder so that the cell sample collector can be preloaded into the speculum 100 prior to use. The rod of the cell sample collector will then project towards the distal, viewing end of the speculum 20 and can be manipulated to remove the cell sample collector from the clip holder.

The U-shaped support 60 on the inside surface of the fixed blade 2 of the speculum 100 acts as a support and/or fulcrum for the rod, to allow greater control when positioning the brush head. When the brush is applied with the required pressure the bristles of the brush head will be flexed against the cervix 300. Two revolutions of the brush will generally be sufficient to collect the required cells.

The cell sample collector is carefully removed from the vagina taking care not to touch the brush against the vagina walls. The LEDs 75,76 are then switched off by clicking the switch 70 and the speculum blades 1,2 are closed by rotating the handles (clockwise from the practitioner's perspective, anti-clockwise from the user's perspective), before the device is removed.

The cell sample is stored by inserting the cell sample collector into a vial, catching the brush head under the opposed ridges on the inside of the vial and pulling the rod off the brush so that the brush head is left inside the vial. The vial and cell sample can then be sent off to the appropriate testing facility.